We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Intercept (ICPT) Ocaliva Wins Positive CHMP Opinion for PBC
Read MoreHide Full Article
Intercept Pharmaceuticals, Inc. announced that that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval of Ocaliva (obeticholic acid/OCA) for the treatment of primary biliary cholangitis (PBC).
Note that the European Commission (EC) generally takes the CHMP’s opinion into account while reviewing drug applications but is not bound to abide by the same.
The positive opinion was based on efficacy and safety data from three randomized double-blind, placebo-controlled studies that evaluated the effect of OCA on alkaline phosphatase (ALP) and bilirubin in PBC patients.
However, Intercept is required to provide post-approval data from the safety and efficacy analyses of the ongoing phase IV COBALT study and a short-term study in patients with hepatic impairment.
We remind investors that in May 2016, Ocaliva, in combination with ursodeoxycholic acid (UDCA), was approved in the U.S. for the treatment of PBC in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
We note that UDCA is the only drug approved in the U.S. for PBC. PBC affects approximately one in 1,000 women aged over 40 years. Hence, there is significant unmet need for therapies in this space.
Intercept Pharma currently carries a Zacks Rank #3 (Hold).
Exelixis has beaten earnings estimates twice in the last four quarters with an average surprise of 9.10%.
Incyte’s earnings estimates for 2016 and 2017 were up a respective 22.2% and 6.6% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.
Geron has delivered a positive earnings surprise twice in the last four trailing quarters, bringing the average beat to 20.78%.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Intercept (ICPT) Ocaliva Wins Positive CHMP Opinion for PBC
Intercept Pharmaceuticals, Inc. announced that that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval of Ocaliva (obeticholic acid/OCA) for the treatment of primary biliary cholangitis (PBC).
Note that the European Commission (EC) generally takes the CHMP’s opinion into account while reviewing drug applications but is not bound to abide by the same.
The positive opinion was based on efficacy and safety data from three randomized double-blind, placebo-controlled studies that evaluated the effect of OCA on alkaline phosphatase (ALP) and bilirubin in PBC patients.
However, Intercept is required to provide post-approval data from the safety and efficacy analyses of the ongoing phase IV COBALT study and a short-term study in patients with hepatic impairment.
INTERCEPT PHARM Price
INTERCEPT PHARM Price | INTERCEPT PHARM Quote
We remind investors that in May 2016, Ocaliva, in combination with ursodeoxycholic acid (UDCA), was approved in the U.S. for the treatment of PBC in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
We note that UDCA is the only drug approved in the U.S. for PBC. PBC affects approximately one in 1,000 women aged over 40 years. Hence, there is significant unmet need for therapies in this space.
Intercept Pharma currently carries a Zacks Rank #3 (Hold).
Stocks to Consider
Some better-ranked stocks in the health care sector are Exelixis, Inc. (EXEL - Free Report) , Incyte Corporation (INCY - Free Report) and Geron Corporation (GERN - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Exelixis has beaten earnings estimates twice in the last four quarters with an average surprise of 9.10%.
Incyte’s earnings estimates for 2016 and 2017 were up a respective 22.2% and 6.6% over the last 60 days. The company has beaten earnings estimates thrice in the last four quarters with an average surprise of 335.16%.
Geron has delivered a positive earnings surprise twice in the last four trailing quarters, bringing the average beat to 20.78%.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>